The present invention relates to parenteral injection training devices including devices that simulate an injection time or a resistance of a filled injection device or syringe.
Many people take medications one or more times a day to maintain or improve their health. Often, these medications must be delivered by injection or parenterally, that is, taken into the body or administered in a manner other than through the digestive tract.
If medications are not taken in the proper manner, individual health may be jeopardized. For example, failure to take a complete injection for treatment of diabetes can result in severe health consequences, including death. Non-compliance with a prescribed dose regimen includes patients who fail to properly inject their medication or only inject a portion of their medication.
Further, failure to properly inject medications, particularly in the elderly and the aging population, can result in billions of dollars of unnecessary health care costs because expensive medications can be wasted in the process. That is, an incomplete injection, often leaves expensive or necessary medication in a syringe that is disposed of in the garbage.
An injection (often referred to as a “shot” is an infusion method of putting fluid into the body, usually with a hollow needle and a syringe which is pierced through the skin to a sufficient depth for the material to be forced into the body. An injection follows a parenteral route of administration; that is, administered other than through the digestive tract.
Some medications must be delivered into the body parenterally. It is common for manufacturer's of such medications to provide medication for injection in pre-filled syringes. Common syringes, whether pre-filled, or filled by the patient, manual or auto-injection, typically utilize a hollow needle for delivering a liquid medication from the syringe into the body. Theses medications are typically stored in a cylinder having a hollow needle connected to a cylindrical reservoir and having a plunger for forcing the liquid medication from the reservoir, through the needle, into the body.
When force is applied to the plunger by mechanical means, such as in an auto-injection syringe or manually, by the person administering the injection, the medicine is forced through the needle into the body. There is a resistance caused by the liquid medicine being forced through a needle. The magnitude of the resistance dictates the time that it takes to force all the medicine through the needle and complete the injection.
An auto-injector is a medical device designed to deliver a single dose of a particular, typically life-saving, drug but may be provided for many kinds of drugs.
Most auto-injectors operate as spring-loaded syringes. By design, auto-injectors are easy to use and are intended for self-administration by patients, or administration by untrained personnel. The site of injection depends on the drug loaded, but administration typically is into the arm, thigh or the buttocks. These injectors were initially designed to overcome the hesitation associated with self-administration of a needle-based drug delivery device.
An auto-injector typically keeps the needle tip shielded prior to injection and also may have a safety mechanism to prevent accidental firing (injection). Injection depth can be adjustable or fixed and a function for needle shield removal may be incorporated. By pressing a button, the syringe needle is automatically inserted and the drug is delivered. Once the injection is completed some auto injectors have visual indication to confirm that the full dose has been delivered. Auto-injectors may contain glass syringes, this can make them fragile and contamination can occur. More recently, companies have been making auto-injectors syringes using plastic to prevent this issue.
Patients require training in the operation of a an auto-injector or manual syringe. Known methods of training patients include using an actual auto-injector or manual syringe. These methods are impractical and undesirable because patients would receive multiple or unnecessary injections. While it is possible to use a known injection device without the medication or without a needle, such a simulation would not accurately replicate an actual injection. For example, without liquid medication in the injection device, the patient would inject too quickly because there is no liquid present to resist the force applied to a plunger. Thus, in such a case, a patient would be trained to believe that the injection process is much faster than an actual injection and may, in actual practice, pull the needle out of their skin too early thus receiving an inadequate dose of medication.
Some known training devices simply remove liquid medicine from the actual injection device in order to use the empty unit as an injection trainer. As mentioned above, this approach does not accurately simulate the duration or the force required in an actual injection.
Novel injection training devices that can be reusable and can accurately simulate an injection time or resistance and methods of training for improving patient compliance in parenteral administration of liquid medications are disclosed herein.